BLA 761262

ABBVIE INC

FDA Drug Application

Application #761262

Documents

• Letter: 2022-06-17
• Label: 2022-06-21
• Medication Guide: 2022-06-21
• Letter: 2022-09-26
• Label: 2022-09-27
• Medication Guide: 2022-09-27
• Label: 2022-11-28

Application Sponsors

BLA 761262

ABBVIE INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

150MG

0

SKYRIZI

RISANKIZUMAB-RZAA

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-06-16

PRIORITY

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761262
            [companyName] => ABBVIE INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761262s000lbl.pdf#page=29"]
            [products] => [{"drugName":"SKYRIZI","activeIngredients":"RISANKIZUMAB-RZAA","strength":"600MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/16\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761262s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761262s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761262Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-06-16
        )

)